ID

23414

Description

Clinical Study ID: 100450 Study Title: Comparative study of the immunogenicity and protective efficacy of GlaxoSmithKline Biologicals’ rec-DNA hepatitis B vaccine with or without hepatitis B immunoglobulins (HBIg) in newborns of HBeAg+ mothers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00240526 https://clinicaltrials.gov/ct2/show/NCT00240526 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix-B Study Indication: Hepatitis B Documentation part: Visit 21, Year 15, Long Term Follow-Up, 15 Years +/- 6 Months

Link

https://clinicaltrials.gov/ct2/show/NCT00240526

Keywords

Versions (1)
  1. 7/4/17 7/4/17 -
Uploaded on

July 4, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Rec-DNA hepatitis B vaccine with or without hepatitis B immunoglobulins Visit 21 NCT00240526

English

Visit 21 Rec-DNA hepatitis B vaccine with or without hepatitis B immunoglobulins NCT00240526

1 forms  
Informed Consent
Description

Informed Consent

Alias
UMLS CUI-1
C0021430
UMLS CUI-2
C0474232
Center
Description

Center

Data type

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Date of Visit
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Informed Consent Date
Description

I certify that Informed Consent has been obtained prior to any study procedure.

Data type

time

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0011008
Demographics
Description

Demographics

Alias
UMLS CUI-1
C0011298
UMLS CUI-2
C0474232
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Race
Description

Race

Data type

integer

Alias
UMLS CUI [1]
C0034510
Race
Description

If Other, please specify

Data type

integer

Alias
UMLS CUI [1]
C0034510
Height
Description

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Laboratory Tests
Description

Laboratory Tests

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0005834
UMLS CUI-3
C0474232
Has a blood sample been taken?
Description

blood sample

Data type

boolean

Alias
UMLS CUI [1]
C0005834
Date sample taken
Description

Please complete only if different from visit date

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Did the subject receive a dose of Hepatitis B vaccine since the last visit
Description

Hepatitis B vaccine

Data type

boolean

Alias
UMLS CUI [1]
C2240392
Did the subject develop clinical signs possibly related to hepatitis B since last visit or suffered from hepatitis B?
Description

hepatitis B

Data type

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C1457887
UMLS CUI [2]
C0267797
If Yes, please specify
Description

Did the subject develop clinical signs possibly related to hepatitis B since last visit or suffered from hepatitis B?

Data type

text

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C1457887
UMLS CUI [2]
C0267797
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Similar models

Visit 21 Rec-DNA hepatitis B vaccine with or without hepatitis B immunoglobulins NCT00240526

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Informed Consent
C0021430 (UMLS CUI-1)
C0474232 (UMLS CUI-2)
Center
Item
Center
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Informed Consent Date
Item
Informed Consent Date
time
C0021430 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Demographics
C0011298 (UMLS CUI-1)
C0474232 (UMLS CUI-2)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (M)
CL Item
Female (F)
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
Black (1)
CL Item
Arabic/North African (2)
CL Item
White/Caucasian (3)
CL Item
East & South East Asian (4)
CL Item
South Asian (5)
CL Item
Other (6)
Race
Item
Race
integer
C0034510 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Item Group
Laboratory Tests
C0022885 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
C0474232 (UMLS CUI-3)
blood sample
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Date sample taken
Item
Date sample taken
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Hepatitis B vaccine
Item
Did the subject receive a dose of Hepatitis B vaccine since the last visit
boolean
C2240392 (UMLS CUI [1])
hepatitis B
Item
Did the subject develop clinical signs possibly related to hepatitis B since last visit or suffered from hepatitis B?
boolean
C0019163 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0267797 (UMLS CUI [2])
hepatitis B
Item
If Yes, please specify
text
C0019163 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0267797 (UMLS CUI [2])
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